The scientists took blood samples to measure resting blood glucose and levels of potassium, sodium, insulin, creatine, and C-peptide
(a measure of how much insulin someone is producing).
Chronic overeating increased the amount of total body fat and visceral fat as well as post-meal blood sugar and C-peptide
He presented with a hypoglycaemic episode at postnatal day one (blood glucose was 1.33 mmol/L and simultaneous insulin level was 22.7 [micro]IU/mL, C-peptide
5.42 ng/mL (0.9-7.1).
The initial analysis of the one-year follow-up data for all subjects shows that CLBS03 was well tolerated at the doses tested in the study, however, no improvement in the primary endpoint of preservation of C-peptide
At the 4th hour of the prolonged fasting test the insulin value was determined as 28.4 (6-27) lU/dL and c-peptide
: 5 (1.1-5) lU/dL while blood glucose was measured as 30 mg/dL.
Also, the levels of C-peptide
, an indicator of the amount of insulin produced, also registered an increase in the subjects receiving the supplement over the placebo-receiving subjects.
After adjustment for insulin sensitivity, steady-state C-peptide
fell slightly in each group (P = 0.34 between groups) and acute C-peptide
response to arginine at maximum glycemic potentiation fell significantly in the metformin group (P = 0.002) but not in the band group (P = 0.25 between groups).
On admission, laboratory analyses showed hyperglycemia, a relatively low level of C-peptide
, elevated glycated hemoglobin (HbA1c), a low level of triglycerides and negative autoantibodies regarding diabetes (Table I).
If the patients met one of the following criteria, they were diagnosed with T1DM: (1) severe insulin deficiency (fasting serum C-peptide
<0.01 ng/ml); (2) if they had residual beta-cell function (fasting serum C-peptide
ranging from 0.01 to 0.6 ng/ml), they depended on insulin treatment within 5 years of diabetes duration; and (3) persistently positive autoantibody associated with T1DM.
The company's standardized method mimics embryonic development to manufacture large quantities of cryopreserved beta cells that secrete insulin and C-peptide
, making the cells an excellent research tool for disease modeling and drug discovery.
For the third criterion, urinary C-peptide
excretion <10 ug/day or fasting serum C-peptide
<0.3 ng/ml or post meal or post intravenous glucagon serum C-peptide
Cohort 2 is expected to enroll up to 40 patients; the primary efficacy measurement will be the clinically relevant production of insulin, as measured by the insulin biomarker C-peptide
, in a patient population that has little to no ability to produce endogenous insulin at the time of enrollment.